DREAM Study: DNA/RNA-NGS Co-Testing in Driver-Negative, Treatment-Resistant NSCLC

Last updated: February 20, 2025
Sponsor: Baohui Han
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Treatment

This study did not include intervention between the two cohorts

Clinical Study ID

NCT06846762
ShanghaiChestIS25009
  • All Genders

Study Summary

The study is divided into two parts, Part A and Part B. The purpose of Part A is to reveal the proportion of NSCLC patients who are primarily resistant to first-line non-targeted therapy due to the omission of driver genes (especially fusion variations) by DNA-NGS, the median PFS of patients in the first line, and clinical characteristics through synchronous co-testing of DNA and RNA NGS. The purpose of Part B is to compare the difference in ORR between patients with driver gene positivity identified through synchronous co-testing of DNA and RNA NGS who receive and do not receive targeted therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 and above, male or female

  2. Pathologically diagnosed with advanced or metastatic inoperable non-small cell lungcancer

  3. Prior genetic testing [DNA-NGS] results show no mutations in EGFR, BRAF, MET, HER2,KRAS, FGFR2/3，no amplifications in MET and HER2 and no fusions in ALK, ROS1, RET,NTRK, NRG1, EGFR, MET, BRAF, FGFR2/3

  4. Based on negative driver gene results, received first-line non-targeted therapy withrapid progression or intolerance, with a progression-free survival (PFS) of ≤6months (regardless of drug exposure time, calculated from the first day ofmedication)

  5. Have retained tumor tissue samples prior to first-line treatment

  6. Patients are from medical centers that can ethically affiliate and have accessibleclinical follow-up data.

Exclusion

Exclusion Criteria:

  1. Patients who do not meet any of the necessary inclusion criteria

  2. Presence of other pulmonary diseases that require treatment or are severe, includingbut not limited to active pulmonary tuberculosis, interstitial lung disease, etc.

  3. Presence of active infections that require systemic treatment

  4. History of drug abuse or alcohol abuse, or mental illness, or suspected allergy orintolerance to the study drug or any of its components

  5. Any other conditions deemed unsuitable for entry into this study by theinvestigator.

Study Design

Total Participants: 508
Treatment Group(s): 1
Primary Treatment: This study did not include intervention between the two cohorts
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
January 01, 2027

Connect with a study center

  • Shanghai Chest Hospital

    ShangHai, Shanghai 200030
    China

    Active - Recruiting

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